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drug3128 | Prototype swab Wiki | 1.00 |
drug1042 | Control swab Wiki | 1.00 |
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Navigate: Correlations HPO
There is one clinical trial.
This project aims to determine whether a comprehensive cardiac rehabilitation program including supervised exercise training is able to prevent cardiotoxicity during treatment with anthracyclines and / or anti-HER-2 antibodies in women with breast cancer. Participants will be randomly allocated to cardiac rehabilitation (intervention group) or conventional management with physical exercise recommendation (control group).
Description: Fall of 10 absolute percentage points of left ventricular ejection fraction with final value below 53% or global longitudinal strain fall >15% with respect to baseline
Measure: Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography Time: Baseline to every 3 months through study completion, at the end of the study at an average of 18 months, and every year after study completion up to a maximum of 5 yearsDescription: Score achieved in the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire, a specific validated scale to assess quality of life of women with breast cancer. It comprises 27 items within 5 areas of assessment: physical well-being (7 items), social and family environment (7 items), emotional well-being (7 items), functional well-being (6 items) and worries related to the diagnosis and treatment of the disease (9 items). Each item is scored by means of a Likert scale from 0 to 5, with higher scores representing better results. The total score is obtained by adding the scores for each item, and ranges from a minimum of 0 (worst posible result) to a maximum of 146 (best possible result).
Measure: Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire Time: Baseline and at the end of the study at an average of 18 monthsDescription: Significant cardiovascular and non-cardiovascular adverse effects during treatment, threatening life, requiring admission, prolonging hospitalization, being clinically relevant or causing chemotherapy interruptions
Measure: Change in tolerance to chemotherapy: number of participants with significant cardiovascular and non-cardiovascular adverse effects throughout the study Time: Every 3 months during study completion and at the end of the study at an average of 18 monthsDescription: Change in functional capacity assessed by conventional ergometry, cardiopulmonary exercise test or the 6-minute walking test (6MWT) (metabolic equivalents: METs or peak oxygen consumption: VO2) * . *Due to COVID-19 pandemic, participants' assessment with CPET had to be stopped for safety concerns. In such cases, functional capacity was estimated from the maximum work rate in the 6-minute walking test (6MWT). This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes, which is well correlated with VO2. The 6MWT has been proved to be valid and reliable for functional capacity assessment in the study population.
Measure: Change in global functional capacity assessed by conventional ergometry, cardiopulmonary exercise testing (CPET) or the 6-minute walking test (6MWT). Time: Baseline and at the end of the study at an average of 18 monthsDescription: Number of repetitions in the sit-to-stand test within 30 seconds
Measure: Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test Time: Baseline and at the end of the study at an average of 18 monthsDescription: Range of degrees in shoulder movement measured by goniometry
Measure: Change in shoulder functional capacity assessed by range of degrees in shoulder movement by goniometry Time: Baseline and at the end of the study at an average of 18 monthsDescription: Kilograms by dynamometry of right and left upper limbs
Measure: Change in upper limb strength measured by dynamometry (kg) Time: Baseline and at the end of the study at an average of 18 monthsDescription: Score achieved in the SPADI (shoulder pain and disability index) questionnaire. The pain dimension consists of five questions regarding the severity of an individual's pain, functional activities are assessed with eight questions. Each question may be scored from 0 to 10. Verbal anchors for the pain dimension are 'no pain at all' (0) and 'worst pain imaginable' (10) ,and those for the functional activities are 'no difficulty' (0) and 'so difficult it required help' (10). The scores from both dimensions are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Measure: Change in shoulder pain and disability assessed by the SPADI (shoulder pain and disability index (SPADI) questionnaire Time: Baseline and at the end of the study at an average of 18 monthsDescription: Dyslipidemia, Diabetes mellitus, Arterial Hypertension, Smoking status
Measure: Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors Time: Baseline and at the end of the study at an average of 18 monthsDescription: Height measured in cm
Measure: Change in anthropometric parameters: height in cm Time: Baseline and at the end of the study at an average of 18 monthsDescription: Weight measured in kg
Measure: Change in anthropometric parameters: weight in kg Time: Baseline and at the end of the study at an average of 18 monthsDescription: Weight and height will be combined to report BMI in kg/m^2
Measure: Change in anthropometric parameters: body mass index (BMI) in kg/m^2 Time: Baseline and at the end of the study at an average of 18 monthsDescription: Abdominal perimeter measured with a tape measure in cm
Measure: Change in anthropometric parameters: abdominal circumference in cm Time: Baseline and at the end of the study at an average of 18 monthsDescription: Resting heart rate by pulse oximetry (beats per min)
Measure: Change in resting heart rate measured by pulse oximetry (beats per min) Time: Baseline and at the end of the study at an average of 18 monthsDescription: Resting blood pressure by sphyngomanometer in mmHg
Measure: Change in resting blood pressure (mmHg) measured by sphygmomanometer Time: Baseline and at the end of the study at an average of 18 monthsDescription: Value of NT-ProBNP(pg/mL) in blood tests
Measure: Change in biomarkers NT-ProBNP Time: Baseline and at the end of the study at an average of 18 monthsDescription: Value of troponin I (ng/mL) in blood tests
Measure: Change in biomarkers: troponin Time: Baseline and at the end of the study at an average of 18 monthsDescription: Value of haemoglobin (g/dL) in blood tests
Measure: Change in biomarkers: haemoglobin Time: Baseline and at the end of the study at an average of 18 monthsDescription: Validated questionnaire to assess adherence to Mediterranean diet, including 14 questions regarding dietary habits, rated with 0 or +1 points. Global score is calculated by summing points and ranges from 0 to 14, with higher score representing higher adherence.
Measure: Change in dietary pattern as assessed by the PREDIMED (PREvención con DIeta MEDiterránea) questionnaire Time: Baseline and at the end of the study at an average of 18 monthsDescription: Score achieved in the depression subscale of the Zigmond and Snaith test for anxiety or depression, a self-applied questionnaire. Depression scale includes 7 items each, scored on Likert scale from 0 to 3. Global score ranges from 0 to 21, with higher scores representing greater depression. The authors suggest that scores higher than eleven would indicate "case" and more than eight would be considered "probable case" (Zigmond and Snaith, 1983).
Measure: Change in the score for depression assessed by Zigmond and Snaith questionnaire to rate anxiety and depression Time: Baseline and at study completion at an average of 18 months, plus at the end of training (at an average of 12 to 15 months) in the intervention groupDescription: Score achieved in the anxiety subscale of the Zigmond and Snaith test for anxiety or depression, a self-applied questionnaire. Anxiety scale includes 7 items each, scored on Likert scale from 0 to 3. Global score ranges from 0 to 21, with higher scores representing greater anxiety. The authors suggest that scores higher than eleven would indicate "case" and more than eight would be considered "probable case" (Zigmond and Snaith, 1983).
Measure: Change in the score for anxiety assessed by the Zigmond and Snaith questionnaire to rate depression and anxiety Time: Baseline and at study completion, plus at the end of training (at an average of 12 to 15 months) in the intervention groupDescription: Minutes of In- and out-of-hospital dedicated physical activity
Measure: Change in physical activity (minutes of dedicated physical activity) Time: Baseline and at study completion at an average of 18 monthsDescription: Score achieved in the Godin Leisure Test Exercise Questionnaire (GLTEQ) for quantification of physical activity. Activities are classified into three subgroups: "strenuous," "moderate," and "light." The scores corresponding to the energy expenditure (metabolic equivalent (MET)) are obtained by multiplying activities performed for more than 15 min in a week with their coefficients. The numbers represent the MET intensity values (strenuous/ exhausting exercises: 9 METs, moderate exercises: 5 METs, and light exercises: 3 METs).The increasing scores are associated with the increasing number of exercise behaviors, providing references about the contribution of physical activity to health: the activity score of 24 units and more as active (substantial benefits); the activity score of 14-23 units as moderately active (some benefits); and the activity score of 13 units and less as inactive (less substantial or low benefits).
Measure: Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ) Time: Baseline and at study completion at an average of 18 monthsDescription: Perimeter of the upper limb by cirtometry (cm), stage and grade as defined by the Spanish Society of Rehabilitation and Physical Medicine
Measure: Change in lymphedema assessed by perimeter of the upper limb by cirtometry (cm), stage and grade Time: Baseline after surgery and 2-4 weeks after the end of chemotherapy (at an average of 12 to 15 months)Description: Number of training sessions attended / number of sessions planned
Measure: Adherence and compliance to cardiac rehabilitation program (intervention group) assessed by number of training sessions attended/ number of sessions planned Time: At the end of the cardiac rehabilitation program at an average of 12 to 15 monthsDescription: Adverse events during training
Measure: Security of the cardiac rehabilitation program assessed by number of adverse events during training (intervention group) Time: At the end of the cardiac rehabilitation program at an average of 12 to 15 monthsDescription: Program-related expectations at baseline and at the end of the program' are collected through an open question "What do you expect to achieve by participating in the program?" Responses regarding expectations will be categorized by the evaluator within the following areas: psychological sphere and/or social sphere and/or physical sphere. Global expectations of benefit are scored from 0 (no benefit) to 10 (highest benefit).
Measure: Changes in expectations regarding the cardiac rehabilitation program assessed by a questionnaire (intervention group) Time: Baseline and at the end of the cardiac rehabilitation program at an average of 12 to 15 monthsDescription: Satisfaction at the end of the program is assessed by a questionnaire including 9 questions concerning comfort with training sessions, training spaces and development of the program, which are scored from 0 (worse posible result) to 10 (best posible result). Total score is calculated by adding for each question, and ranges from 0 to 90. * Due to the introduction of telematic exercise training during COVID-19 pandemic, questions were slightly modified to include assessment of satisfaction with this training modality.
Measure: Satisfaction with the cardiac rehabilitation program assessed by a questionnaire (intervention group) Time: At the end of the cardiac rehabilitation program at an average of 12 to 15 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports